The Health Care Blog – Page 534 – Everything you always wanted to know about the Health Care system. But were afraid to ask.

Above the Fold

Regulating Health IT: When, Who, and How?

Sep 10, 2013• 7

By Rebecca L. Jewell, Esq. & Dan Haley

Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.

Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.

Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.

But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.

The Not Normals Break Through — An Update From the Khan Academy

Sep 9, 2013• 2

By MICHAEL PAINTER, MD

If you’re going to get ambitious about your next task, don’t go and talk to normal people about it. You’ll only get normal answers. Get out of your comfortable little world and step into a completely alien one. As we say round here, when worlds collide, transformation happens.

Love that passage from Brian Millar’s 2012 Fast Company piece. (Plus, it gives me the awesome chance to nod to the eccentrics and outliers—like Millar’s dominatrix and tattooed hipster set—and their unlikely importance to pioneering, breakthrough ideas).

Recently RWJF extended another grant to the Khan Academy; this one for $1.25 million. I say another as we started this health education journey with Sal, Rishi and the Khan team—right after Sal’s outstanding 2011 TED/Long Beach talk. That discussion resulted in a preliminary 2012 $350,000 bet on this great team. We were intrigued by their big idea—and we thought the world might be too.

What’s that big idea again? Just this: an entirely free, utterly fantastic health education for anyone in the world with a computer and an Internet connection.

Potentially crazy? Perhaps. Ambitious? No kidding. But for RWJF’s pioneering work, that’s right where we like to be. We thought there just might be something there. One year later, we are even more convinced. In that time, the Khan team has pushed intensely and hard—creating its new Healthcare and Medicine Initiative basically from scratch.

For instance, with our support, Khan staff have developed about 200 videos now posted on that Healthcare and Medicine Initiative site—as well as their YouTube medical channel. These videos have received about 800,000 views, and the site has over 10,000 new subscribers. Khan continues to work with Stanford Medical School. That collaboration includes developing and posting Stanford Medical School content on the Khan site as well as integrating the online format into traditional medical school courses.Continue reading…

The Shocking Truth About Medication Errors

Sep 9, 2013• 8

By Leah Binder

Let’s say a physician writes a prescription for Colchicine and accidentally orders “10.0 mg,” when he should have ordered “1.0 mg.” That’s a tiny decimal error, a mistake even the best doctor could make. But it can be catastrophic for the patient. The higher dose could cause Colchicine poisoning, similar to arsenic poisoning: burning in the mouth and throat, excruciating abdominal pain. Internal organs would melt away and death would likely occur within 24 to 72 hours.

The ease with which even the best doctors can make gruesome errors is why hospitals set up elaborate systems to check and double check orders before drugs are given to patients. Some hospitals are better at this checking than others. Medication errors happen all the time, an estimated one million each year, contributing to 7,000 deaths. On average there is one medication error every day for every inpatient. Let’s take a closer look at what’s contributing to these preventable errors.

Hospitals Are In The Technological Dark Ages

According to recent research, the best known way for hospitals to protect patients from errors is by adopting technology called computerized physician order entry (CPOE). The physician (or other authorized prescriber) enters orders for a patient on a computer that contains patient information such as key lab values, clinical condition, allergies, etc. The computer checks the safety and appropriateness of the order and sends it electronically to the pharmacy. In the Colchicine example, a good CPOE system would alert the physician to the misplaced decimal in the order, and the best systems would prevent the order from being written in the first place. In my mind, one of the greatest advances of CPOE is that it eliminates the need for pharmacists to decipher physician handwriting. I’ve often wondered how they do that.

The research suggests errors decline by as much as 85 percent when hospitals implement CPOE, yet the pace of adoption in the hospital industry is agonizingly slow. To jump start progress, the federal government used economic stimulus funds starting back in 2009 to incentivize hospital investment in CPOE and electronic medical records (EMRs). That improved the pace of change, but still, most hospitals are in the Dark Ages when compared to other industries like airlines or retail.

My nonprofit, Leapfrog, finds that only about a third of the hospitals that voluntarily report to our survey meet our standard for full implementation of CPOE. Even for that minority of hospitals that adopt CPOE, the system doesn’t always work as advertised. Like all technology, CPOE must be continually tested and modified. That’s not always happening.

The 9th Grade Class Does Obamacare Math (Can Journalists Do the Same?)

Sep 8, 2013• 9

By Michael L. Millenson

Welcome, students, to our special combined 9^th grade math and civics class. Today, we’re going to look at the “Cadillac tax” in the Affordable Care Act.

Yes, Mitt, you have a question already? No, no, “Cadillac tax” is just an expression. No one is going to tax your family’s cars, Mitt, I promise.

Paul, you also have a question? I’m sorry, Paul, but if you had done the reading, you would know that the “Affordable Care Act” and “Obamacare” are the same thing. And yes, it is still the law, as I must have told you and your friends 40 times. Now can we get on with the class?

As those of you who did do the reading know, most American workers get their health insurance through their employer. The company, in turn, is allowed to deduct the cost of that insurance from its taxes. If the insurance for workers is very generous, it can encourage people to use too much medical care. This not only drives up costs, but we all pay for it a second time through the tax code. The Affordable Care Act addresses that problem by placing an excise tax on rich benefit plans starting in 2018, which is informally known as the “Cadillac tax.”

Economists of all viewpoints generally agree that an open-ended tax deduction for health insurance encourages overconsumption. What do we call that kind of agreement? Michelle?

No, Michelle, I’m afraid, “liberal conspiracy” is not the answer I was looking for. “Bipartisan consensus” was the correct response.

Rand, you seem quite agitated. Yes? “Government intervention in markets is never the right answer.” OK. Well, Rand, let’s talk about that another time and move on from civics to the mathematics part of today’s lesson. We’ll start with a word problem from the New York Times.

The Times quoted a study from a health policy journal as saying that 75 percent of health plans could be affected by the Cadillac tax over the next decade. That’s a big number, isn’t it? And the tax itself is 40 percent – another big number. No wonder the story was on the first page of the Business section.

But here are a few other numbers from the same study: just 16 percent of plans are likely be affected by the tax when it starts in 2018 – a much smaller number. And the “next decade” the study is talking about starts in 2018. What the study actually says is that by 2029 the tax could reduce benefits for affected plans by 3.1 percent. That’s an even smaller number and even further away.

Class, why would the New York Times emphasize the biggest numbers they could find?

ESCAPE FIRE: Changing Medical Education

Sep 7, 2013• 5

Since its Sundance premiere in 2012, ESCAPE FIRE has screened for national leaders, medical experts, thousands of students, and the general public. The film opened in theatres last October, and had its broadcast premiere on CNN March 10th. From the Pentagon to local communities, ESCAPE FIRE has reached an incredibly diverse audience.

Last year, ESCAPE FIRE: The Fight to Rescue American Healthcare screened on college campuses nation-wide two weeks before opening in theaters. Almost 6,000 students came together to watch the award-winning documentary, and to host discussions about the current state of the American healthcare system. The sentiments from these discussions became calls to action: service projects, course work, and blogs for undergraduates and medical students across the nation.

This year we’re doing it all again. On September 17th, ESCAPE FIRE will play at more than 60 college and university campuses across the country, followed by panel discussions and Q&As. We’ve partnered with the Institute for Healthcare Improvement (IHI), one of the widest-reaching non-profit health organizations in the US, to make sure as many students are aware of the opportunity as possible.

We’re taking the event a step further this year by donating an Educational copy of ESCAPE FIRE to each participating campus, allowing the event to incite change for years to come. Our hope is that students, after attending an entertaining event and participating in thoughtful conversations about their communities, will take on an active role in transforming healthcare.

In order to make sure this discussion doesn’t stop after school or with student groups, we have accredited ESCAPE FIRE for both Continuing Medical Education units and Continuing Nursing Education contact hours. Now, anyone who views the film, can get educational credit. And for the week of September 17th through 30th, the film will be available on iTunes for $0.99.

This is a unique and unprecedented chance for healthcare providers to utilise the film to elevate and deepen the national dialogue about our healthcare system and our role in leading it out of crisis.

Spread the word about this event on Facebook and Twitter. And find a screening near you.

A New Way to Sue Health Care Professionals Using HIPAA?

Sep 6, 2013• 20

By Pathology Blawgger

Walgreens has been ordered to pay $1.44 million in a lawsuit brought against it for a violation of the Health Insurance Portability and Accountability Act (HIPAA) by one of its pharmacist employees. While this may not sound like a big deal, this case represents only the second time HIPAA has been successfully used this way in court and it could have serious repercussions on the health care system.

The story begins when a Walgreens pharmacist looked up the medical records of her husband’s ex-girlfriend, whom she suspected gave her husband an STD. Apparently she found what she was looking for and told her husband about it, who then sent a text message to his ex and informed her that he knew all about her results.

The ex did not appreciate this, and told the Walgreens pharmacy about what happened. At some point after that, the pharmacist accessed the ex’s medical records again, and eventually the ex filed a lawsuit against Walgreens, claiming it was responsible for the HIPAA violation because it failed to properly educate and supervise its employee.

Walgreens argued what the pharmacist did fell outside of her job duties and therefore it was not responsible for the breach. The judge and jury disagreed, and the jury decided Walgreens was responsible for 80% of the damages owed the plaintiff (so I guess that means the total judgement for the plaintiff was $1.8 million). Walgreens has already said it will appeal.

As I said above, it may not sound like a big deal, but it potentially is.

Although HIPAA has a mechanism by which health care providers can be subject to federal civil and criminal penalties for violations, conventional legal wisdom says HIPAA does not allow for a “private cause of action”, meaning a private individual cannot sue a health care provider for breaching their medical privacy.

Or at least that’s how HIPAA used to be interpreted, before Neal Eggeson, the enterprising young attorney who successfully argued the only two cases in which HIPAA has been used in this fashion, came along.

When Foundation-Approved Apps Founder

Sep 6, 2013• 11

By Leslie Kernisan, MD

What does it mean when an app wins a major foundation’s developer challenge, and then isn’t updated for two and a half years?

Today, as I was doing a little background research on task management apps for caregivers, I came across a 2012 post listing Pain Care as a handy app for caregivers.

Pain is certainly something that comes up a lot when it comes to geriatrics and supporting caregivers, so I decided to learn a little more about this app.

“The Pain Care app won the “Project HealthDesign” challenge by the Robert Wood Johnson Foundation and California HealthCare Foundation,” reads the descriptive text in the Google Play Store.

Well, well, well! RWJF and CHCF are big respectable players in my world, so I was impressed.

But then as I looked at the user reviews, I noticed something odd. Namely, that the most recent one seems to be from April 2012, which is like 2-3 generations ago when it comes to apps.

And furthermore, the app itself was last updated in February 2011. This is like a lifetime ago when it comes to apps.

I decided to download the app and give it a whirl. It’s ok. Seems to be an app for journaling and documenting pain episodes, along with associated triggers. Really looks like something developed by doctors: one of the options for describing the type of pain is “lancinating,” and in a list of “side-effects” (side effects of what? the pain medication one may have just taken?) there is the option to check “sexual dysfunction.” Or you could check “Difficulty with breathing.” (In case you just overdosed on your opiates, perhaps.)

The app does connect to a browser-based account where I was able to view a summary of the pain episode I’d documented. It looked like something that one should print and give to a doctor, and in truth, it would probably be helpful.

Setting snarky comments about the vocabulary aside: this app actually looks like a good start for a pain journal. But it needs improvement and refining, in order to improve usability and quality. Also, although I don’t know much about app development and maintenance, I assume that apps should be periodically upgraded to maintain good performance as the operating systems of iPhones and Android phones evolve.

The Exchanges Won’t Be Ready in Time. And it Probably Won’t Matter.

Sep 5, 2013• 7

By Dan Diamond

As states race to implement health reform, California doesn’t want to settle for second.

“We don’t want to be a pace car state” when it comes to implementing health reform, state HHS Secretary Diana Dooley told Politico back in January 2011. “We want to be the lead car.”

It’s a metaphor that California leaders have returned to time and again. And to their credit, they’ve often succeeded.

While other states waffled, Golden State officials quickly embraced key Obamacare provisions like expanding Medicaid and creating insurance pools for individuals with pre-existing conditions.

At the same time, lawmakers crafted legislation intended to conform California’s health insurance plans to new standards under the Affordable Care Act.

And Covered California, the state’s health insurance exchange, also has drawn national attention for its speedy implementation. Among the 17 states that opted to run their own exchanges, California has “certainly [been] in the lead on getting their health plan information out … and getting the contracts signed,” Rachel Dolan, who monitors exchange activity for State Refor(u)m, a project of the National Academy of State Health Policy, said.

But the driving metaphor only extends so far.

“I don’t think it’s a race,” Dolan added, cautioning that each state might take unique approaches to exchange implementation — and objectively judging those individual strategies is impossible.

And a more essential issue might be getting lost, amid the growing number of questions over which state exchanges will be open for business on Oct. 1.

“Lots of people are asking about readiness,” said Caroline Pearson, who leads Avalere Health’s efforts to track health reform implementation. “But no one is asking about whether it matters.”

Where the States Stand on Readiness
The sprint to get the exchanges off the ground — which for some states didn’t really begin in earnest until after the Supreme Court’s June 2012 decision to uphold the ACA — has led to repeated delays and ongoing concerns.

What Keeps Me Up At Night – 2013 Edition

Sep 5, 2013• 11

By John Halamka, MD

Now that Labor Day has come and gone, I’ve thought about the months ahead and the major challenges I’ll face.

1. Mergers and Acquisitions

Healthcare in the US is not a system of care, it’s a disconnected collection of hospitals, clinics, pharmacies, labs, and imaging centers. As the Affordable Care Act rolls out, many accountable care organizations are realizing that the only way to survive is to create “systemness” through mergers, acquisitions, and affiliations. The workflow to support systemness may require different IT approaches than we’ve used in the past. We’ve been successful to date by leaving existing applications in place and building bidirectional clinical sharing interfaces via “magic button” viewing and state HIE summary exchange. Interfacing is great for many purposes. Integration is better for others, such as enterprise appointment scheduling and care management. Requirements for systemness have not yet been defined, but there could be significant future work ahead to replace existing systems with a single integrated application.

2. Regulatory uncertainty

Will ICD10 proceed on the October 1, 2014 timeline? All indications in Washington are that deadlines will not be changed. Yet, I’m concerned that payers, providers and government will not be ready to support the workflow changes required for successful ICD10 implementation. Will all aspects of the new HIPAA Omnibus rule be enforced including the “self pay” provision which restricts information flow to payers? Hospitals nationwide are not sure how to comply with the new requirements. Will Meaningful Use Stage 2 proceed on the current aggressive timeline? Products to support MU2 are still being certified yet hospitals are expected to begin attestation reporting periods as early as October 1. With Farzad Mostashari’s departure from ONC, the new national coordinator will have to address these challenging implementation questions against a backdrop of a Congress which wants to see the national HIT program move faster.

3. Meaningful Use Stage 2 challenges

Although attestation criteria are very clear (and achievable), certification is quite complex, especially for a small self development shop like mine. One of my colleagues at a healthcare institution in another state noted that 50 developers and 4 full analysts are hard at work at certification for their self built systems. I have 25 developers and a part time analyst available for the task. I’ve read every script and there are numerous areas in certification which go beyond the functionality needed for attestation. Many EHR vendors have described their certification burden to me. I am hopeful that ONC re-examines the certification process and does two things – removes those sections that add unnecessary complexity and makes certification clinically relevant by using scenarios that demonstrate a real world workflow supporting the functionality needed for attestation.

Why Nurse Practitioners Will Not Solve the Primary Care Crisis

Sep 4, 2013• 11

By Nicole Fisher

In coming years the US could see growing shortages in the availability of primary care physicians (PCPs). With the number of individuals seeking care increasing and the current medical system continuing to incentivize physicians to specialize, the number of available PCPs will decline proportional to the population. To fill that gap, Ezra Klein and others have asserted that expanded scope of practice will allow nurse practitioners (NPs) to serve as viable substitutes for primary care shortages.

While NPs serve a vital role in the system and meet need, the argument that they are a 1:1 substitute for PCPs (but for the greedy doctors and pesky regulations holding them back) is singular and shortsighted. The argument also fails to address broader policies that influence both NP and PCP behaviors. Policies that unjustifiably lead to the unequal distribution of caregivers, location or expertise, inherently parlay into unequal care for patients. Sadly, a broader scope than “freeing nurse practitioners” is necessary to meet primary care needs, as NPs are complements, not substitutes. Policy must address the need for more primary care and assist to realign the system to meet our country’s basic care and equality through redistribution.

Primary care is the foundation of the evolving health care system, with equal access the intended goal of the ACA. Along the way to meeting future demand for primary care, NPs can be increasingly utilized to meet the needs of Americans and improve the health of the nation. And let it be known I am a strong proponent and supporter of nurse practitioners and all non-physician providers and coordinators. However, the argument that most NPs practice in primary care and will fill the primary care gap, estimated at about 66 million Americans, is inaccurate. It isn’t a 1:1 substitute, especially given that models of the solo practitioner are vanishing in lieu of complementary and team-based care.

The US, unlike many western countries, does not actively regulate the number, type, or geographic distribution of its health workforce, deferring to market forces instead. Those market forces, however, are paired with a payment system whose incentives favor high volume, high return services rather than health or outcomes. These incentives are reflected in where hospitals steer funding for training, and in the outputs of that training.

Throughout the US there are geographic pockets that fail to attract medical professionals of all kinds, creating true primary care deserts. These deserts occur in part due to the unequal distribution of practitioners in the health care system, with our medical schools and salary opportunities producing low numbers of generalists across the board. We have even continued to see shortages in nurses throughout the US.